Biomerieux recall: Vitek 2 Ast-N461 Test Kit
Biomerieux Inc is recalling Vitek 2 Ast-N461 Test Kit – 97680 units. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on July 24, 2026. Distributed International distribution to the countries of Austria, Germany, Luxembourg..
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Vitek 2 Ast-N461 Test Kit |
| Brand | Biomerieux |
| Company | Biomerieux Inc |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 24, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 97680 units |
| Recall ID | 99749 |
Recalled products
- VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
- FDA recall number
- Z-3231-2026
- Codes, lots and dates
- UDI-DI 03573026637712; Lot Number 1333393504
- Quantity
- 97680 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99749
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Hazelwood, MO, United States
Why it was recalled
The reason the FDA lists: “The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.”
Where it was sold
Distribution as the FDA records it: “International distribution to the countries of Austria, Germany, Luxembourg.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99749, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
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About this recall
Is Biomerieux Vitek 2 Ast-N461 Test Kit recalled?
Yes. Biomerieux Inc recalled it on July 24, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
International distribution to the countries of Austria, Germany, Luxembourg..
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.